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NCT05589896 · ClinicalTrials.gov registry record · Phase 1
A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
A Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Ossium Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 9
- Study locations
NCT05589896: Recruiting Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Ossium Health.
NCT05589896 is a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Ossium Health. The registered enrollment target is 12 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (90% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05589896, a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Ossium Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 9
- Study locations
Study Summary
The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.
Primary Outcome
Neutrophil engraftment is defined as achieving an absolute neutrophil count (ANC) of greater than or equal to 500/µL for 3 consecutive measurements on 3 different days by Day 28.
Conditions Studied
Interventions
- OTHER Ossium HPC Marrow, Bone Marrow Transplant
- OTHER Pre-transplant conditioning - Myeloablative (MAC)
- OTHER Pre-transplant conditioning - Reduced Intensity (RIC)
- OTHER Post-transplant treatment
Study Locations (9)
Texas
- St. David's South Austin Medical Center - Austin
- Methodist Hospital, Texas Transplant - San Antonio
California
- City of Hope - Duarte
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Emory University - Winship Cancer Institute - Atlanta
Michigan
- Henry Ford Cancer Institute - Detroit
Oregon
- Oregon Health and Science University - Portland
Tennessee
- TriStar Bone Marrow Transplant - Nashville
Utah
- University of Utah - Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-08-16 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
What NCT05589896 shows while recruiting
NCT05589896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (90% lower).
The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Ossium HPC Marrow, Bone Marrow Transplant is the first listed.
NCT05589896 lists 9 locations in 8 states (Texas, California, Florida).
Frequently Asked Questions
What is clinical trial NCT05589896 about?
NCT05589896 is a clinical study titled "A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies". The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or re...
What is the current status of trial NCT05589896?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-08-16. Estimated completion is 2027-03-31.
What conditions does trial NCT05589896 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Leukemia, Hodgkin's Lymphoma, Acute Biphenotypic Leukemia.
What interventions are being tested in trial NCT05589896?
The interventions under investigation include: Ossium HPC Marrow, Bone Marrow Transplant (OTHER), Pre-transplant conditioning - Myeloablative (MAC) (OTHER), Pre-transplant conditioning - Reduced Intensity (RIC) (OTHER), Post-transplant treatment (OTHER).
Who is sponsoring clinical trial NCT05589896?
This trial is sponsored by Ossium Health, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05589896 being conducted?
This trial has 9 study locations across California, Florida, Georgia, Michigan, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05589896's enrollment target sits among peer trials
12 288th of 306 higher than 17 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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